Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04018118

Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

Unexplained chronic hypereosinophilia (HE) and hypereosinophilic syndromes (HES) are heterogeneous regarding the organ involvements (heart, lungs, skin, .. or none), the evolutionary profiles, the response to treatments.

Underlying mechanisms are largely unknown and may associate genetic predisposing factors (germinal ? somatic?), environmental factors (alimentation, tobacco use, hormones, infections, ..) The COHESion study aims to study all clinical and biological characteristics of HE/HES patients and their evolutionary profiles, with a focus on genetic factors and the mechanisms supporting transitory or persistant chronic HE/HES (in absence of any well identified extrinsic trigger like drugs, parasitosis, ..)

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHU

Lille, France

Location status: Recruiting

Location contact

Guillaume Lefevre, MD,PhD

PRINCIPAL_INVESTIGATOR

About this study

There is currently no data on the natural history of unexplained chronic hypereosinophilia (HE) and hypereosinophilic syndromes (HES). Clinical practice shows that HE/SHE patients can present 4 evolutionary profiles:

A. a single flare-up of their disease, with favourable evolution spontaneously or under corticosteroid therapy, without further recurrence B. recurrent flare-ups with a variable free interval of several months to several years, with or without persistent eosinophilia between flare-ups C. a chronic disease requiring the continuation of a substantive treatment D. chronic asymptomatic HE for years: the mechanisms involved in the occurrence of possible organ damage are unknown

The primary objective of the study is to describe the frequency of the different clinical manifestations during the diagnostic and follow-up of the hypereosinophilic syndrome (HES). The primary endpoint is the frequency of the different clinical manifestations and/or organs damage related to eosinophilia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or Women of any age :
  • With the diagnosis criteria of hyperosinophlia OR hypereosinophilic syndrome OR specific organ eosinophilic disease according to the consensus conference of the International Cooperative Working Group on Eosinophil Disorders (ICOG-EO)
  • With an AEC > 1500/mm3 or organ damage related to the presence of eosinophils in the tissues or organs whatever the context (idiopathic, clonal or reactive, including drug-related, parasitic or allergic)
  • HES diagnosis since 2005/01/01
  • Patients socially insured
  • Patient who agreed to participate to the study, its proceedings and duration.

Exclusion criteria

  • Known HIV infection
  • Not socially insured
  • Person unable to receive a enlighten information
  • Person who refuse to sign the consent
  • Persons deprived of their liberty
  • Persons benefiting from a system of legal protection (tutelage / guardianship)

Treatment and study plan

biological sample

Biological

Additional blood samples for biobanking

Primary outcomes

  1. Frequency of the different clinical manifestations at time of diagnosis and during follow-up of the hypereosinophilic syndrome (HES)

    Time frame: 10 years

    The primary objective of the study is to describe the frequency of the different clinical manifestations at diagnosis and during follow-up of the hypereosinophilic syndrome (HES/HE). The primary endpoint is the frequency of the different clinical manifestations and/or organs damage related to hypereosinophilia.

Secondary outcomes

  1. Frequency of the evolutionary profiles

    Time frame: 10 years

    Frequency of the different evolutionary profiles.

  2. Frequency of complications depending of the type of HES

    Time frame: 10 years

    Frequency of complications (organ damages) depending on the type of HES (idiopathic, reactive, clonal…).

  3. Frequency of organ damage profiles before and after 18 years old.

    Time frame: 10 years

    Describe the characteristics of pediatrics HE/HES vs adult HE/HES.

  4. Frequency of clinical complications profiles before and after 18 years old.

    Time frame: 10 years

    Clinical characteristics of pediatrics HE/HES vs adult HE/HES.

  5. Frequency of HLA alleles and variants / mutations on other genes of HE/HES

    Time frame: 10 years

    Predisposing factors in HE/HES by various genomic approaches

  6. Serum biomarkers

    Time frame: 10 years

    to explore Potential predisposing factors in HE/HES: serum markers predictive of interest in eosinophilopoiesis (IL5), tissue homing (eotaxins, etc.)

  7. Difference in Membrane activation markers of HE patients (asymptomatic) versus SHE (symptomatic).

    Time frame: 10 years

    Predisposing factors in HE/HES by various genomic approaches

  8. Difference in Eosinophilic gene expression profiles of HE patients (asymptomatic) versus SHE (symptomatic).

    Time frame: 10 years

    Predisposing factors in HE/HES by various genomic approaches

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Lefevre, MD

CONTACT

[email protected]

03 20 44 55 72 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Study of Clinical Profiles of Patients Followed for Chronic Hypereosinophilia and/or Hypereosinophilic Syndrome by the Creation of a National Cohort

Acronym: COHESION

Important dates

Study start
2019
Primary completion
2029
Study completion
2031
First posted
Jul 12, 2019
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.